Fluocinolone Acetonide Implants: Uses and Risks

Fluocinolone acetonide implants are sustained-release devices that put a steroid into the eye for years.

Clinicians also use them for chronic noninfectious posterior uveitis and for diabetic macular edema that has persisted despite other treatments.

They can control disease with a single procedure, but they bring a high rate of cataract and raised pressure.

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Fluocinolone Acetonide Implant: Why Sustained Release?

Chronic eye inflammation and persistent edema often need repeated injections, with their cost and risk.

A device that releases a low dose of steroid steadily over months to years reduces the number of procedures and keeps drug levels more even.

Also, fluocinolone is a potent steroid that is lipophilic and has low solubility, which makes it suitable for slow release.

Fluocinolone Acetonide Implant Devices

• Retisert (0.59 milligram): a surgically implanted device, sutured to the sclera through a pars plana incision, releasing drug for about 30 months, approved for chronic noninfectious posterior uveitis
• Iluvien (0.19 milligram): a small injectable implant placed through a 25-gauge needle, releasing drug for up to 36 months, approved in many countries for chronic diabetic macular edema
• Yutiq (0.18 milligram): an injectable implant for chronic noninfectious uveitis affecting the posterior segment, with a duration of about 36 months

Product availability and approved indications vary between countries, so check the local label.

Evidence in Diabetic Macular Edema

The FAME trials randomized patients with persistent diabetic macular edema to low-dose or high-dose fluocinolone inserts, or to sham.

At three years, a greater proportion of treated eyes gained 15 or more letters than sham eyes.

The benefit was greater in patients with chronic edema, of more than three years’ duration (see the references).

Investigators saw the benefit mostly in pseudophakic eyes, since cataract was frequent in phakic eyes.

The implant is therefore chosen mainly for pseudophakic patients with persistent edema that responds poorly to other treatments (see diabetic macular edema).

Evidence in Uveitis

In the Multicenter Uveitis Steroid Treatment trial, investigators randomized patients with intermediate, posterior, or panuveitis to the Retisert implant or to systemic therapy.

Both approaches controlled inflammation and improved vision. The implant group, however, had higher rates of raised pressure and cataract surgery. It also had lower rates of the systemic side effects of drugs (see the references).

In addition, the implant can allow patients to avoid long-term systemic steroids, which is helpful in some cases (see uveitic macular edema).

Complications of Fluocinolone Acetonide Implant

• Cataract: very common in phakic eyes, with most requiring surgery within a few years
• Raised intraocular pressure: frequent, with a significant number needing medications. Some needing laser or glaucoma surgery (see steroid-induced glaucoma)
• Implant-related problems: for the surgical device, hypotony, vitreous hemorrhage, retinal detachment, and endophthalmitis; for the injectable implants, migration and extrusion
• Rebound inflammation when the drug is exhausted

Patients need regular monitoring, and the plan for pressure control should be in place before treatment.

Who Is a Candidate?

• Pseudophakic patients with persistent diabetic macular edema after other treatments
• Patients with chronic uveitis who have not responded to or cannot tolerate systemic therapy
• Patients who have shown a good response to a steroid test, such as a short-acting injection, without a severe pressure rise
• Those who understand the need for follow-up and the likelihood of cataract and pressure problems

Doctors often use a steroid challenge with a short-acting injection as a test before placing a long-acting implant.

Counselling

Explain that the implant is a long-term treatment, that it works for a long time, and that cataract and pressure rise are common.

Describe the plan for monitoring, and tell the patient that the implant cannot be removed easily in some cases.

Selecting the Right Patient in Practice

A pseudophakic diabetic patient with edema that has persisted through several anti-VEGF injections and a prior steroid injection, and who has shown no pressure rise, is the typical candidate for the injectable implant.

Doctors may also consider the uveitis implant for a patient with chronic posterior uveitis who cannot tolerate systemic immunosuppression, or who has unilateral disease.

Before the procedure, record the pressure, the lens status, and the optic nerve, and agree on the plan for pressure drops and cataract surgery.

Fluocinolone Acetonide Implant: Follow-Up Schedule

• Review the pressure at one week, one month, and then every three months
• Obtain OCT at each visit to document the macular response
• Watch for the return of edema or inflammation as the drug runs out toward the end of the stated duration
• Discuss options at that time, including a repeat implant in selected patients

Patients should keep their appointments, and should report pain, redness, or loss of vision at once.

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References

1. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626-635.
2. Kempen JH, Altaweel MM, Holbrook JT, et al. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the Multicenter Uveitis Steroid Treatment Trial. Ophthalmology. 2011;118:1916-1926.
3. Ryan SJ, Schachat AP, Wilkinson CP, et al, eds. Retina. 6th ed. Elsevier; 2018.
4. American Academy of Ophthalmology. Basic and Clinical Science Course, Section 9: Uveitis and Ocular Inflammation. AAO; current edition.